Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Overview

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Detailed description

Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility-sparing treatment in endometrial cancer recommend weight management. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Interventions

• Behavioral Weight management--diet
  The diet structure adopts an energy-limited balanced diet. In this structure, the total daily energy intake is reduced by 500\~1000 kcal based on the target energy intake; however, the balance is maintained for the energy supply ratio of the three major nutrients (with carbohydrate, protein, and fat accounting for 55\~60%, 10\~20%, and 15\~30% of the total daily energy, respectively). Combined with the patient's eating habits, the food exchange portion method is used as a guide; each portion pro
• Behavioral Weight management--exercise
  Exercise goals are divided into four levels based on individual health conditions and personal preferences; these include: cultivating exercise habits, improving cardiopulmonary function, enhancing muscle strength, and improving flexibility. Individualized exercise prescriptions that specify the exercise type, intensity, time, and frequency are formulated.
• Behavioral Weight management--accompany
  This component involves the inclusion of patients in online management. Online groups are established, daily feedback is obtained regarding weight management implementation, self-sharing is encouraged, and peer support is established; a total of 6 sessions of online health education are provided once every 4 weeks for 20-60 minutes at each session. This includes information regarding the risks associated with overweightness and obesity; weight management benefits; knowledge regarding diet and nu
• Behavioral Weight management--refresh
  According to the dietary nutrition guidelines for Chinese residents, patients are advised to drink 2500 ml or more of water daily; they are also advised to work and rest regularly to ensure sufficient sleep time, ensure smooth bowel movements, take deep breaths when waking up in the morning, pay attention to the work-rest balance, avoid being sedentary, and stand up and move around at least once every 50 minutes, maintain physical vitality by adjusting daily living habits.
• Behavioral Control group
  The relationship between overweightness and obesity and endometrial cancer risk was explained to patients in the control group and their willingness for self-weight management was respected. Communication was maintained with patients from treatment initiation to 3 and 6 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.

Primary outcome measures

• Body Mass Index（BMI）--physiological parameter [Time frame: 6 months of intervention]
• waist-to-height ratio (WHtR)--physiological parameter [Time frame: 6 months of intervention]
• waist-to-hip ratio (WHR)--physiological parameter [Time frame: 6 months of intervention]
• body shape index (ABSI)--physiological parameter [Time frame: 6 months of intervention]
• body roundness index (BRI)--physiological parameter [Time frame: 6 months of intervention]
• visceral fat index (VAI)--physiological parameter [Time frame: 6 months of intervention]
• lipid accumulation index (LAP) (female)--physiological parameter [Time frame: 6 months of intervention]
• waist circumference--physiological parameter [Time frame: 6 months of intervention]
• hip circumference--physiological parameter [Time frame: 6 months of intervention]
• body fat mass (BFM)--physiological parameter [Time frame: 6 months of intervention]

Secondary outcome measures (3)

• Complete remission [Time frame: 6 months of intervention]
• Recurrence [Time frame: 6 months of intervention]
• Pregnancy [Time frame: 2 years of intervention]

Eligibility criteria

Inclusion criteria

• age ≥18 years old
• diagnosed as endometrial cancer or atypical hyperplasia
• immunohistochemical staining and sequencing of pathological tissue
• fertility-preserving therapy
• BMI≥25 kg/m2
• informed consent.

Exclusion criteria

• those with communication barriers
• pregnant women
• medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University People's Hospital — Beijing

Publications

• Chen Y, Yang J, Wan Y, Li Q, Yang D, Wang Y, Gong J, Bai L, Liu Y, Li X, Wang J. DEAR model in overweight endometrial cancer patients undergoing fertility-sparing treatment: A randomized controlled trial. Gynecol Oncol. 2024 Jun;185:148-155. doi: 10.1016/j.ygyno.2024.02.017. Epub 2024 Feb 28. PMID 38422947

Identifiers

NCT: NCT06169449 · RDL2022-49

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗